A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease

Summary

This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of Cellular biology based therapeutic drug evaluation committee (CBBTDEC).

Timeline

Start

2017-02-20

Primary completion

2018-04

Completion

2019-10

Outcome

Outcome not reported

Stopped: “Form 46 from DCGI for the manufacturing \& commercial marketing of Stempeucel® directs Stempeutics to conduct PMS study. Hence this study is being terminated.”

Drugs

Indications